Will Congress move to stop women’s health disaster?
We first met U.S. Rep. Mike Fitzpatrick as he was walking along a New Year's Day parade in downtown Yardley, Pa. We approached him with our six children in tow and asked if he had a moment to hear our story.
We told him about how a medical device, known as a "power morcellator", had for over two decades been spreading occult uterine cancers to an incurable advanced stage in up to one in 350 women who undergo morcellation.
You can read about this devastating hazard here and here.
After listening to us for about 45 minutes in the cold rain, he said his office would be in touch. A few weeks later, we got the call. Fitzpatrick wrote a letter of inquiry to the FDA commissioner on Feb. 19 about how this medical device had stayed on the market for so long.
Fitzpatrick promised to inform the leadership and ranking members of the congressional committee on Energy and Commerce (E&C) of this issue, including Chairman Fred Upton (MI-06), Subcommittee on Health Chairman, Joe Pitts (PA-16) and Subcommittee on Oversight and Investigation Chairman, Tim Murphy (PA-18). He also brought the matter to subcommittee on Health, Dr. Michael Burgess (TX-26), a gynecologist.
Our multiple queries to Pitts for a comment on this topic have gone unanswered. Burgess single-handedly dismantled 12 common sense "concern of congress" amendments to a House bill, known as "21st Century Cures", proposed by Fitzpatrick. Our repeated requests for comment from Burgess have also gone unanswered.
In the meanwhile, Fitzpatrick rallied a bipartisan group of 12 colleagues in the House to request an investigation of the power morcellator by the Government Accountability Office (GAO). This investigation will be initiated shortly.
Almost nine months after Fitzpatrick's letter to FDA was submitted, he received a "partial-response" on November 12, authored by the FDA's Acting Associate Commissioner on Legislation, Dayle Cristinzio.
In this letter FDA confirmed that hospitals and medical device manufacturers have a legal duty to self-report adverse outcomes and deaths related to the use of medical devices. FDA also confirmed that in the case of power morcellators, no adverse outcomes had been reported until December 2013 - 20 years after the device began causing harm.
When the hazard finally was reported, it was patients, their families and advocates that brought the problem to the FDA.
On Nov. 17, Murphy's office alerted us to a hearing being held that day at which the congressman would be questioning witnesses on "Examining the Regulation of Diagnostic Tests and Laboratory Operations.''
The witness was the director of the FDA's Center for Devices and Radiological Health, Dr. Jeffrey Shuren. Here is the exchange between Shuren and Murphy at the hearing – which makes it clear that Murphy recognizes that several medical device manufacturers and hospital corporations violated federal law by failing to report harm caused by morcellation. It also makes it clear that Murphy is joining Fitzpatrick in speaking out on the matter.
Time will tell if Congress as a whole follows the lead of these Pennsylvania Republicans in addressing this women's health disaster.
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